An Idea Factory for Pathology Informatics and the Clinical Laboratory. Presented by the Pathology Education Consortium (PEC).

27 posts categorized "Blood Banking"

I started my career as a blood banker in 1973 and switched to pathology informatics in 1982. For this period of nine years, the idea of "artificial blood" was very hot, funded largely by the military. Obviously, the military has a keen interest in a blood substitute with long shelf life, no requirement for crossmatching, and no fear of disease transmission. Fast forward to the present time when the hope of a practical blood substitute has yet to be fulfilled. A recent article provided an interesting perspective on this topic (see: Another Step Closer to Artificial Blood). Below is an excerpt from it:

Researchers have created an artificial red blood cell that effectively picks up oxygen in the lungs and delivers it to tissues throughout the body. This artificial blood can be freeze-dried, making it easier for combat medics and paramedics to keep on hand for emergencies, said senior researcher Dr. Allan Doctor....It's a dried powder that looks like paprika, basically ....It can be stored in an IV plastic bag that a medic would carry, either in their ambulance or in a backpack, for a year or more. When they need to use it, they spike the bag with sterile water, mix it, and it's ready to inject right then and there. The artificial blood cell, which is about one-fiftieth the size of a normal red blood cell, is made from purified human hemoglobin proteins that have been coated with a synthetic polymer....The hunt for an artificial blood substitute has been underway for more than 80 years, but the closest prior attempts have failed in two major ways....Earlier versions could capture oxygen in the lungs, but then would not effectively release the oxygen after traveling out to tissues and organs....There also was an unintended reaction between "naked" hemoglobin and nitric oxide, a substance released by the lining of blood vessels that allows the vessels to relax and open up....The polymer coating also keeps the hemoglobin from reacting with nitric oxide in the bloodstream, thus preventing dangerous constriction of the blood vessels....There's also one more benefit -- because the polymer coating is "immune silent," the artificial blood can be used in anyone regardless of blood type....Lab tests involving mice and rats have proven that the artificial red blood cells can effectively deliver oxygen to needy tissues....Besides emergency settings, the artificial blood also could be used to help keep donated organs alive on route to a recipient....

The research on artificial blood continues unabated. What's interesting to me about the article about Doctor's research is that he has apparently come to the conclusion that it's extremely difficult to duplicate the function of human hemoglobin in terms of oxygen capture and release. He has thus wrapped hemoglobin with a synthetic polymer to prevent undesirable reactions between the "naked hemoglobin molecule" and the nitric oxide released by the lining of blood vessels. However, Doctor has bigger ideas in mind for his research than a blood substitute, although that would be a great gift for transfusion medicine. Here is an excerpt from his lab's home page:

[T[he long term goal of the studies in my lab is to define the role of red blood cells (RBCs) in the spread of vascular dysfunction during oxidative stress, as exemplified by the development of secondary lung injury. Impaired pulmonary vascular control occurs early in respiratory failure complicating systemic inflammation. This pulmonary vascular dysregulation is characterized by loss of coupling between regional vascular tone and oxygen gradients (e.g. ventilation – perfusion mismatching). While nitric oxide (NO) signaling has been implicated, there is no clear mechanism linking remote inflammation to downstream lung injury. New data suggest that NO groups circulate and signal remotely through serial NO-thiol transfer reactions.

I have recently concluded that the term "best-of-breed LIS" has ceased to be useful as products like Epic's Beaker approach the functionality of competing LISs. Beaker still lacks a blood bank module which causes customers to seek one from another vendor. Epic has been assisted in its pursuit of BoB status in part by the publication of the LIS Functionality Assessment Toolkit (LIS-FAT) by the Association for Pathology Informatics (see: The laboratory information system functionality assessment tool: Ensuring optimal software support for your laboratory; Toolkit Components). This detailed list of both mission critical and desirable LIS functions has operated as a roadmap for vendors such as Epic that wanted to improve their LISs to satisfy the EHR market. I think that the best-of-breed label thus no longer provides the ability to differentiate between vendors specializing in the lab market and those that offer an LIS module as a component of a much broader hospital-wide enterprise-wide software suite. I also suggest here that a new label, specialized lab software (SLS) vendor, should he used to refer to the specialized lab software vendors.

I cite Sunquest Information Systems as the best example of a prominent SLS vendor in order to better understand the value that is provided by the company. In recent months, Sunquest and its parent company Roper Technologies have purchased three companies, Data Innovations, Atlas Medical, and GeneInsight, all of which offer highly specialized products. To better understand the degree of specialization offered by these firms, one need only look at Data Innovations (DI) as an example. It's the leading global supplier of instrument interfaces. Such interfaces are a mission-critical component for the Beaker LIS as well as for the instruments sold by the major in-vitro diagnostic companies. As a make-or-buy decision, Epic and the IVD companies have decided that the domain expertise to develop instrument interfaces is such that they turn to DI to supply interfaces to their customers. The IVD companies, of course, have complete mastery over the development of the software/firmware necessary to operate their analyzers. However, their interest, enthusiasm, and market success for middleware, the software that sits between instruments and the LIS inducing interfaces and rules engines, has been limited over the years.

There is no question that Beaker benefits from certain advantages in the LIS market, notably the desire of hospital executives to seek an "integrated" solution from Epic. On the other hand and as a major SLS vendor, Sunquest may seek to develop pathology and lab software products that may be too specialized or too market-limited for Epic to pursue. The following seven examples come quickly to mind:

Physician portal and lab outreach software.

Molecular pathology and cancer genomics software.

Anatomic pathology automation software.

Pathology consultation network software.

Pathology and lab analytics software with emphasis on lab operations.

Digital pathology software.

Image analysis software.

What then is the take-home lesson from this discussion for lab professionals who may be in the process of considering the purchase of a new LIS? The pursuit of the maximum functionality from any software purchase is, as always, a key factor in such a process. Computers substitute for labor in in this era of value-based care and software is critical in the automation of most lab tasks. For an EHR/enterprise-wide solution deployment, many of the functionality and financial benefits may lie outside of pathology and the labs. In the final analysis, however, pathology departments will always need to develop a relationship with one or more SLS vendors, both large and small, to provide lab and pathology software and functionalities not offered by their EHR vendor.

With the rise of companies like Uber, entrepreneurs in a variety of fields are extending the concept of connecting customers and workers in what is sometimes called the new sharing economy....Many taxi drivers dislike the competition from Uber, but we need to think more systematically about the winners and losers as these new institutions develop. The greater convenience they provide consumers is obvious, but is this generally a good or bad thing for people on the other side of the market, the workers? One recent study...suggested that Uber drivers earned more than typical taxi drivers and chauffeurs....Such services are likely to continue to spread. If they do, what else is there to say about their broader implications?....Uber drivers are much more likely to have a college degree than are taxi drivers or chauffeurs, according to ...[a recent] study. It found striking differences between the two groups: 48 percent of Uber drivers have a college degree or higher, whereas that figure is only 18 percent for taxi drivers and chauffeurs....

To get a better handle on how some workers might lose, consider a hypothetical situation in which such services ...do not exist. Let’s say a software company receives periodic contracts to execute projects, but it has to rely entirely on current full-time staff. The company then must train its workers to handle a wide variety of possible projects, and so the amount and cost of corporate in-house education go up. But all things being equal, because this training costs something to the company, worker wages will be lower. ....But some self-starting workers might have learned the material on their own anyway. Those workers receive more in-house education than they need, which, in turn, means they are paid lower wages and might well be worse off than they would have been in an economy that encourages self-training and freelance opportunities. One implication is that if the Uber idea spreads, it could discourage corporate training and may require that workers have stronger educational backgrounds.

In my blog note about how an uberized economy might affect pathology I floated the following idea:

There may be a number of positions in, say, pathology and hospitals where an on-line workforce could be tapped into periodically. In short, there may be times of unexpected work surges when additional personnel such as medical technologists or even pathologists must be quickly sought and an on-line marketplace for such personnel would be helpful. Needless to say, companies that enter into such a market as intermediaries like Uber would need to pay special attention to training, credentials, and reliability of participating personnel.

Running with Cowen's idea, a director of a hospital pathology department might forsake a broad training approach for medical technologists in the labs which could be considered analogous to Tyler Cowen's reference above to "corporate in-house education." Instead, the director might turn to an on-line shared medical technologist service supplying part-time personnel for the blood bank or microbiology. The salary offered to such part time employees could be higher because of the savings realized by the reduction of in-house education. It would be a good "uberized" deal for these part-timers with specialized skills because they could work fewer hours at a higher rate of pay.

The FDA has launched a new app, called DrugShortages, to help health care practitioners and pharmacists track current drug shortages, resolved shortages, and discontinuations of drug products....“The new mobile app [according to an FDA spokesperson,] is an innovative tool that will offer easier and faster access to important drug shortage information. DrugShortages is available on iOS and Android devices. Users can search the database available in the app for a generic name or active ingredient. They can also search for drugs alphabetically or therapeutic category. The app also provides instructions for how an app user can report a drug shortage or supply issue. The FDA hopes the app will help health care practitioners make quick decisions about patient treatment based on the information the app provides. In the past couple years, the FDA has released a few other digital resources for consumers and professionals.In 2012, Epidemico relaunched their app, MedWatcher, in collaboration with the FDA. The app helps consumers report side effects or adverse events of medical devices directly to the FDA....Last summer the FDA launched an API-driven initiative, called openFDA that is designed to help web developers, researchers, and consumers access the FDA’s large public health data sets.The goal for the initiative is to get developers to build their own apps on top of openFDA using the data.

On its web site, OpenFDA describes its mission as providing the following: Open-source APIs for FDA drug, device, and food data. On the home page are listed the following FDA databases as well as the APIs that can be used to guide the development of interfaces to them:

Drugs

Adverse events (api.fda.gov/drug/event

Labeling (api.fda.gov/drug/label)

Enforcement reports (api.fda.gov/drug/enforcement)

Devices

Adverse events (api.fda.gov/device/event)

Enforcement reports (api.fda.gov/device/enforcement)

Foods

Enforcement reports (api.fda.gov/food/enforcement)

It is becoming commonplace for various types of companies to publish open-source APIs that developers can then use to access their often useful, in-house databases and "power consumer-facing applications" (see: The Value of APIs for Business). Here's a quote from this web page describing how a company or governmental agency like the FDA can create value by providing such API's.

When an enterprise business releases public APIs that power consumer-facing applications, it enables new ways to engage and connect with its customers through web, mobile, and social apps....As an example, take the hypothetical case of a national auto insurance provider. Over the years, as part of its normal business operations and planning, it has assembled and maintained comprehensive, detailed, and up-to-date data on the quality and condition of local roads all across the country. By making this previously internal data publicly accessible through an API, the company unleashes the creativity of developers and related businesses to devise new uses for the data. Developers create apps that recommend driving routes based in part on road quality. Civic groups develop apps that empower citizens to band together and petition local officials for better funding of transit infrastructure....Simply exposing this previously isolated and hidden data through a public API has given the insurance company a powerful way to extend its reach to thousands of new customers — who now regularly connect with the company in a more personal, meaningful way.

I started my career as a blood banker about 40 years ago. My job description was crystal clear at that time. My first, and most important task, was to ensure patient transfusion safety. This goal was accomplished with fail-safe patient blood typing and crossmatching of units intended for transfusion. My second important task was to help manage the blood inventory. This was accomplished by ensuring that there were a sufficient number of units in the blood bank based on anticipated need and also by limiting excessive and inappropriate physician blood orders. This latter task certainly had a flavor of clinical transfusion management but the clinicians usually got the product and number that they requested. Here's an excerpt of the description of a job candidate being sought by Santé Consultants that I received recently as an email:

Immediate Opening for a Manager of Blood Utilization/Patient Blood Management in the New York City region.

Santé Consulting has recently been retained by our client to conduct a nationwide search for a Manager of Blood Utilization and Patient Blood Management. Candidates must have MD, or MD, PhD degrees and be certified by the American Board of Pathology in Anatomic and Clinical Pathology or Clinical Pathology only, including Transfusion Medicine and Blood Banking....The job involves assistant directorial and management responsibilities of Transfusion Medicine laboratories; directorial and management responsibilities for the Medical Center Patient Blood Management Program; teaching pathology residents and conducting basic or patient-oriented translational research. The candidate will work closely with the Vice Chair of Clinical Pathology and Director of Blood Bank and Transfusion Service to expand and further modernize the Transfusion Medicine laboratories. This position reports to the Director of Blood Bank and Transfusion Services, and is responsible for directing the Patient Blood Management Program, and assisting in the direction of operations of the Blood Bank, Stem Cell and Immunogenetics laboratories of a major Academic Medical Center.

As described, the pathologist being sought reports to the Director of Blood Bank and Transfusion Services but focuses on blood utilization and patient blood management. This strikes me as being mainly about the why, what, who, and quantity questions relating to transfusion. The emergence of such a position strikes me as interesting. I don't mean to imply here that we did not pay attention to blood utilization four decades ago. We encountered frequent blood shortages that demanded blood management strategies, one example of which was the maximum surgical blood order schedule (MSBOS) (see: Hospitals Seek to Limit Blood Transfusions as a Cost-Saving Measure; Lower Blood Transfusion Rates as a Metric for High Quality Care; The Value of a Restrictive Blood Transfusion Strategy for Hospitalized Patients; Research that Transfusion of "Older" Blood May Be Harmful to Patients). However and to be honest, this blood inventory management tool was designed to limit the time that units of blood inappropriately aging in the OR blood refrigerators. The main idea was to primarily to limit inappropriate crossmatching rather than inappropriate transfusion. Most of our efforts regarding the inappropriate use of product was focused on platelet transfusions, either because the patient had developed immunity to them or to husband a scarce and expensive resource for patients who desperately need the product.

So why this new attention to blood management and utilization control? It's relates partly to the fact that, in some circles, blood transfusion is often deemed useless or even harmful to the patient (see: Avoiding Blood Transfusion as a Hospital Quality and Cost-Savings Measure; ). Secondly, younger physicians, and particularly surgeons, are now trained to use less or no blood. Lastly, blood and blood products are expensive. Curbing inappropriate use is one of the many facets of controlling the cost of healthcare.

I was a blood banker for nine years back in the 70's. For all that time, I was engaged in a constant struggle to increase the blood and blood product inventory while simultaneously tamping down demand, mainly from surgeons. One of the ways that I helped to reduce blood utilization and also increase useful shelf life of blood was with the maximum surgical blood order schedule (MSBOS) that placed limits on the number of units of crossmatched blood that surgeons could order preoperatively and store in the OR refrigerators (see: Hospitals Seek to Limit Blood Transfusions as a Cost-Saving Measure). Now, some four decades later, the tide is beginning to turn. Physicians are realizing that blood transfusion is not a panacea and may harm patients beyond the threat of transmission of infectious disease. Below is an excerpt from a recent article that discusses what appear to be a significant downturn in business for blood banks (see: AS DEMAND DWINDLES, US BLOOD BANKS MAKE CHANGES):

Blood banks are declaring fewer critical shortages these days and in some cases cutting staff in response to dwindling demand for blood - the result of fewer elective surgeries being performed and medical advances that curb bleeding in the operating room. The nation's blood-collection system has undergone a dramatic change from just a decade ago, when agencies that oversee the blood supply worried whether they could keep up with the needs of an aging population. Now blood banks are making fewer but more targeted appeals for donations and reducing the size of their operations. Blood centers shifted "from a collect-as-much-as-you-can mentality to a collect-to-need mentality," said Dr. Darrell Triulzi, medical director for the Institute for Transfusion Medicine in Pittsburgh and a former president of AABB...."They started collecting only what they needed. That's new to the industry. We're still learning how to do that well." Job cuts have been a part of the process.The Indiana Blood Center announced in June that it would eliminate 45 positions in a restructuring that also involved reducing its mobile operations, closing a donor center and cutting other costs because demand from hospitals had fallen 24 percent from the previous year. The Community Blood Center of the Ozarks in Springfield, Mo., announced in March that it was cutting staff by nearly 18 percent. Blood centers in Florida, West Virginia and Connecticut have taken similar steps....The need for blood is still falling even as the economy recovers. Demand dropped by 8.2 percent from 2008 to 2011 and continues to drop....Contributing to the decline are blood-management programs, which include collecting blood lost during an operation and returning it to the patient, maximizing hemoglobin levels to prevent anemia and using medications to reduce bleeding during surgery....Advances in surgical methods, including laparoscopic techniques that use small "keyhole" incisions, have also curbed the need for blood.

My gut instinct tells me that most of the decreasing demand for blood described above is based on three factors: (1) surgeons performing more laparoscopic procedures, including total hips, and adapting to the fact that patients can tolerate relatively low hemoglobin levels post-operatively; (2) pathologists and hospital executives paying even more attention to the cost of blood in this era of intense cost containment; and (3) patients exerting much more influence as consumers of healthcare services and being more aware of the complications of blood transfusion.

There was a time when I, in a previous incarnation as a blood banker, spent a lot of time thinking about the shelf life of blood and how to increase the utilization of blood in blood bank inventory. Hence, a recent article about this topic caught my eye, partly out of a sense of nostalgia (see: The Shelf Life of Donor Blood). Here is an excerpt from it:

For decades, the Food and Drug Administration has limited storage of refrigerated red blood cells to 42 days. But it has been clear for some time that stored blood degrades in various ways long before that six-week limit, and some research suggests that the changes may be harmful to patients who receive older blood. Now a study published in the journal Anesthesia & Analgesia has found that after even 21 days, the membranes of stored blood cells have stiffened, apparently the result of damage over time. That’s a problem because red blood cells are about the same diameter as small capillaries, and they have to change shape to get through.....“What we showed is that the cell membranes lose their flexibility,” said the lead author, Dr. Steven M. Frank....“That makes it more difficult for them to travel through.” The study also found that the older blood cells did not recover their flexibility after being transfused into patients, unlike certain other kinds of changes that blood cells undergo during storage. For example, nitric oxide, essential to keep blood vessels open, is depleted from cells after a few hours of storage, but is restored rapidly after transfusion. Still, researchers do not fully understand the importance of such findings to clinical practice. Even permanent changes in cell structure may not matter, according to [another expert]. “You constantly have blood cells that are getting old in your body, and they’re filtered out,” he said. “It may be that that same system harmlessly filters out these structurally abnormal blood cells.” Two large randomized clinical trials have been undertaken to clear up some of the uncertainties about stored red blood cells.....Dr. Richard J. Benjamin, chief medical officer at the Red Cross, said the two trials would provide important information. If older blood turns out to be less effective, he said, “there are a couple of ways we can respond.” “There are already better storage solutions in development that show drastically improved biochemistry parameters,” he said. “Is the next step to restrict the age of blood for vulnerable populations? ....” As the system works now, the newest blood goes to hospitals that do transfusions infrequently. This gives them time to store the blood safely until it is needed. But it leaves hospitals that use the most blood — trauma hospitals and academic medical centers — with the older blood.

Some highly esteemed hospitals now hold the view that most blood transfusions should be avoided. In short, they view blood transfusion with a jaundiced eye (see: Avoiding Blood Transfusion as a Hospital Quality and Cost-Savings Measure; The Value of a Restrictive Blood Transfusion Strategy for Hospitalized Patients). These hospitals are establishing policies to discourage transfusions on the basis of both cost and quality concerns. Such policies extend beyond the risk of transmitting infectious disease with the blood. I personally don't think that there will be a rapid drop in demand for blood regardless of the results of the two randomized clinical trials referred to in the excerpt above. It's often hard to get older physicians to accept new policies. Rather, I suspect that demand for blood may gradually level off and perhaps even go down slightly in the near future as these anti-transfusion policies extend beyond the few places where they have been already implemented.

The statement [from the article] ...that patients who "received blood transfusions during surgery had higher complication rates afterward and a lower long-term survival rate" is quite dramatic and could probably be challenged. However, the fact that it even appeared in an article about the Cleveland Clinic's quality/cost containment initiatives, in my mind, is highly significant.

In reaction to that note, Dr. Claire Friedman submitted the following comment:

RESULTS: Overall, 30-day mortality was similar in the two [test] groups....However, the rates were significantly lower with the restrictive transfusion strategy among patients who were less acutely ill ...and among patients who were less than 55 years of age ... but not among patients with clinically significant cardiac disease....The mortality rate during hospitalization was significantly lower in the restrictive-strategy group ....

CONCLUSIONS: A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction and unstable angina.

I draw two major conclusions from this article regarding blood transfusion to hospitalized patients. The first point relates to the transfusion trigger, the factor or constellation of factors that precipitate a decision to transfuse blood. I and co-authors coined this phrase in an article published in 1980 (see: An Analysis of Blood Transfusion of Surgical Patients by Sex: A Quest for the Transfusion Trigger). The hemoglobin level has always been used by clinicians as one of the most important factors in assessing the need for blood transfusion. The hemoglobin level used in this regard seems to have trended downward by two or more grams during the last three decades. The second point in the article is that a "restrictive blood transfusion strategy" now seems to be gaining favor. I interpret this to mean that physicians prefer not to transfuse blood at all unless they are pushed to do so. Possible exceptions to this rule are patients with acute myocardial infarctions and unstable angina for whom oxygen delivery to damaged heart muscle takes precedence.

Tucked into a recent news article about the use of multidisciplinary teams (MDTs) at the Cleveland Clinic was the interesting mention of the goal of reducing blood transfusion as both a cost-savings measure and to reduce complications and survival after heart surgery (see: Approaching Illness as a Team). Below is the relevant paragraph:

Data analysis to evaluate how well treatments work is also a big part of the [Cleveland Clinic] medical practice. For instance, the clinic analyzed outcomes for heart surgery patients and found that those who had received blood transfusions during surgery had higher complication rates afterward and a lower long-term survival rate. As a result, it has adopted strict guidelines that limit the use of transfusions. Such judgments about a treatment’s effectiveness are made by doctors, not by financial administrators, so they tend to be accepted....At the same time, the clinic has also carried out simpler reforms, like improving sterile conditions, which has reduced catheter-related bloodstream infections by more than 40 percent and urinary tract infections by 50 percent. All this has happened in a remarkably short time.

All physicians know that there are a number of potential adverse consequences associated with blood transfusions not the least of which is the transmission of infectious diseases (see: Blood transfusion). Blood suppliers and hospital blood banks, of course, run a battery of tests on crossmatched units of blood and components to try to avoid such complications as well as major incompatibility problems.

The statement above that patients who "received blood transfusions during surgery had higher complication rates afterward and a lower long-term survival rate" is quite dramatic and could probably be challenged. However, the fact that it even appeared in an article about the Cleveland Clinic's quality/cost containment initiatives, in my mind, is highly significant. I am seeing a number of other similar article in prestigious journals (see, for example: GI Bleeding: Withholding Transfusion Boosts Survival).

The major reason that I helped to develop the Maximum Surgical Blood Order Schedule (MSBOS) several decades ago was to reduce the excessive number of units of blood that were crossmatched, stored in OR refrigerators, and never transfused (see: Hospitals Seek to Limit Blood Transfusions as a Cost-Saving Measure). However, another more subtle goal was to reduce the number of units transfused to patients simply because they were available in the OR refrigerators. I will see if I can get more information about the new "strict [blood transfusion] guidelines" that have been adopted by the Cleveland Clinic. I am enthusiastic about any measures that reduce unnecessary blood transfusion.

In my note yesterday, I began my personal interpretation of some of the most significant ideas that were discussed during the recent API Strategic Summit (see: Lessons from the API Strategic Summit: Beaker LIS Is Not "Free"). The conference was convened to discuss the future of the LIS and pathology informatics in the era of powerful EMRs. For today's note, I would like to discuss the term best-of-breed LIS. This topic was prompted by a question posed to me at the Strategic Summit by the president of the API, Ray Aller. He asked: why is is only now that we are beginning to grapple with a formal defintion for a best-of-breed (BOB) LIS? The answer is that for approximately four decades, there was no need to define a BOB LIS because everyone thought that they understood the term. In other words, there was a general consensus about the definition. This consensus now seems to be growing weaker.

Simply put, a BOB LIS is a system supplied by a single vendor with a broad range of modules and functionalities, each of which was deemed to be superior, or at least equal, to the competing systems in the market. It was also commonly understood that the LIS market was segmented by hospital/lab size so the return-on-investment (ROI) needed to be factored into this equation. An LIS designed for a large, complex lab might deliver too big and expensive a "payload" for a smaller lab so a different LIS might be considered BOB for that smaller lab segment.

It was axiomatic in the LIS world that the founders of LIS companies had emerged from the clinical lab industry or that the LIS vendors would always hire lab professionals to help design their software and serve as liaisons to lab clients. It was also axiomatic that there was an active "conveyor belt" for ideas about new lab functions between the hospital lab professionals and the LIS vendors. The goal was to continually enhance the LIS software as the overarching lab mission evolved and changed.

The definition for a BOB began to unravel when some vendors began to focus on the requirements of individual labs/functions such as blood bank, surgical pathology, or lab outreach. Some of these specialized vendors began to outshine the "classic LIS vendors" at their own game. In other words, they developed expertise in smaller and more specialized lab niches. An example today is whole-slide-imaging for which specialized vendors provide both hardware (i.e, slide scanners) and the requisite support software. Lab professionals responded by retaining their "classic LIS" but also purchasing these new systems and interfaced them to their classic LISs.

A new, competing model is now rapidly coming to the forefront -- the enterprise-wide-solution (EWS) such as that provided by Epic. Epic views the electronic medical record (EMR), the major software tool used by clinicians, as the epicenter of the hospital computing universe and the functionality requirements of diagnostic departments as subservient. In this Epic model, the company conceptually supplies "shrink-wrap" integration of all modules so that hospital CIO's don't have to deal with the previous "Tower of Babel." An EWS vendor like Epic need not strive to develop a BOB LIS. Beaker only needs to be "good enough" because of the overall appeal of the value proposition of the Epic EMR to CIOs. In response, the hospital lab leadership needs to patch the lab functionality gaps opened by Beaker by deploying "specialized" lab systems or retain their BOB LISs. This is optimistically viewed as a stopgap measure until Epic delivers all the required software solutions.